Rapid exchange catheters usable with embolic protection  devices

ABSTRACT

Catheters, assemblies, and methods for delivering and recovering embolic protection devices. Catheters are provided that can be advanced over single length guide wires and which can be retracted over single length wire shafts of distal embolic protection devices. One catheter is a two-port catheter having two sidewall ports, a distal end port, and a proximal end port. The two-port catheter can be advanced over a guide wire threaded between the distal end port and the distal sidewall port. An embolic protection device wire shaft can be back loaded into the distal end port and out the proximal sidewall port. A three-port catheter includes a distal end port, and distal, intermediate, and proximal sidewall ports. The distal sidewall port can be dimensioned to accept passage of a filter body through the port. The distal end port can be dimensioned to accept only a guide wire to provide a smooth transition from the guide wire to the small profile distal end. The guide wire can extend between the distal end port and the intermediate port while the filter body shaft can extend through the proximal port, to be distally urged through the distal sidewall port. Another catheter embodiment is a slotted catheter, including a biased, normally open slot over most of its length. The slot can be sufficiently small to resist unwanted transverse movement of a wire through the slot. The slotted catheter can be retracted over a wire by forcing the wire through the resilient slot.

This application is a continuation of application Ser. No. 12/021,008,filed Jan. 28, 2008, which is a continuation of application Ser. No.10/171,704, filed Jun. 14, 2002, the contents of each of which arehereby incorporated herein by reference.

FIELD OF THE INVENTION

The present invention is related generally to intravascular medicaldevices. More specifically, the present invention is related to deliveryand recovery catheters which can be used to deliver and recover embolicprotection devices, including distal embolic protection filters.

BACKGROUND OF THE INVENTION

Coronary vessels, partially occluded by plaque, may become totallyoccluded by a thrombus or blood clot causing myocardial infarction,angina and other conditions. A number of medical procedures have beendeveloped to allow for the removal of plaque from vessel walls or toclear a channel through the thrombus or clot to restore blood flow andminimize the risk of myocardial infarction. Carotid, renal, peripheral,and other blood vessels can also be blocked and require treatment. Forexample, atherectomy or thrombectomy devices can be used to removeatheroma or thrombus. Alternatively, in percutaneous transluminalcoronary angioplasty (PTCA), a guide wire and guide catheter areinserted into the femoral artery of a patient near the groin, advancedthrough the artery, over the aorta, and into a coronary artery. Aninflatable balloon is then advanced into the coronary artery, across astenosis or blockage, and the balloon inflated to dilate the blockageand open a flow channel through the partially blocked vessel region. Oneor more stents may also be placed across the dilated region or regions.While some stenoses remain in place once dilated and/or stented, othersare more brittle, and may partially crack and fragment after thedilation or stent placement, allowing the fragments to flow downstreamwhere they may block more distal and smaller coronary vessels, possiblycausing myocardial infarction, from that site. Consequences ofembolization include stroke, diminished renal function, and impairmentof peripheral circulation possibly leading to pain and amputation.

Saphenous vein grafts are often used to bypass occluded coronary vesselsin coronary artery bypass surgery. With time, the grafts can becomeoccluded with grumous. The grumous can also be dilated with balloons orremoved in other ways. The grumous can present an even more difficultmaterial to remove than thrombus, as the material is very friable, andlikely to break into smaller fragments during the removal procedure.

Distal embolic protection devices have been developed to prevent thedownstream travel of materials such as thrombi, grumous, emboli, andplaque fragments. Devices include occlusive devices and filters.Occlusive devices, for example distal inflatable balloon devices, cantotally block fluid flow through the vessel. The material trapped by theinflatable devices can remain in place until removed using a method suchas aspiration. However, aspiration cannot remove large particles becausethey won't fit through the aspiration lumen. Also, aspiration is a weakacting force and won't remove a particle unless the tip of theaspirating catheter is very close to the particle to be removed. Duringthe occlusion, the lack of fluid flow can be deleterious. In coronaryapplications, the lack of perfusing blood flow can cause angina. Incarotids, seizure can result from transient blockage of blood flow. Inboth coronaries and carotids it is not possible to predict who willsuffer from angina or seizure due to vessel occlusion. If a procedure isstarted with an occlusive device, it may be necessary to remove it andstart over with a filter device.

Some distal embolic protection devices include filters. Filters canallow perfusing blood flow during the emboli capture process. Thefilters can be advanced downstream of a site to be treated and expandedto increase the filter area. Emboli, such as grumous or atheromafragments, can be captured in the filter until the procedure is completeor the filter is occluded. When the capacity of the filter is reached,the filter may then be retracted and replaced.

Distal embolic protection devices can be delivered over guide wires andwithin guide catheters. The distal embolic protection methods arenormally practiced ancillary to another medical procedure, for examplePTCA with stenting or atherectomy. The distal embolic protectionprocedure typically protects downstream regions from emboli resultingfrom practicing the therapeutic interventional procedure. In the exampleof PTCA, the treating physician must advance a guide wire over the aortaand into a coronary ostium. Advancing the guide wire through tortuousvessels from a femoral artery approach can be difficult, and vary withboth the patient and the vessel site to be treated. Guide wires aretypically selected by the treating physician, based on facts specific tothe patient and therapeutic situation, and also on the training,experiences, and preferences of the physician. In particular, aphysician may have become very efficient in using a specific guide wireto identify the left coronary ostium and then advance a balloon catheterover the positioned guide wire. The efficacy of the procedure may dependon the physician being able to use their favored guide wire.

The distal embolic protection device is preferably delivered using thesame, favored guide wire. The phrases “distal embolic protection device”or “embolic protection device” are used herein to refer to embolicprotection devices that are occlusive and/or filtering. The terms“distal embolic protection device” and “embolic protection device” areused interchangeably, as either may be used to protect a target sitelocated either proximal to or distal to another treatment site. The term“embolic protection element” may be used generally to include bothocclusive and filtering elements disposed near the distal region of adistal protection device shaft.

In the example PTCA procedure, a guide catheter extends proximally fromthe patient's groin area, and may be about 100 centimeters long, laterhaving a 140 centimeter long guide wire proximal region extending fromthe guide catheter. The distal embolic protection device deliverycatheter, nominally about 130 centimeters in length, can be advancedover the guide wire and within the guide catheter, until a short lengthof guide wire extends from both the guide catheter and deliverycatheter. The guide wire can then be retracted and removed from thepatient. In some methods, the distal protection device is then advancedthrough and out of the positioned delivery catheter, to the target siteto be protected or filtered. In other methods, delivery is accomplishedby disposing the distal embolic protection filter device within thedelivery catheter distal region, and advancing the delivery catheter andembolic protection device together over the guide wire, and deployingthe filter by retracting the delivery catheter while maintaining theposition of the filter, thus forcing the filter distally out of thedelivery catheter.

Advancement of the delivery catheter over a single length, nominally 130centimeter long guide wire presents a problem. The treating physiciancan only advance the filter delivery catheter about 20 centimeters overthe guide wire until the delivery catheter advances into the patient andthe guide wire is inaccessible within the delivery catheter. The guidewire position should be controlled at all times so as to not bedislodged by the advancing delivery catheter from the hard acquiredguide wire position within the patient.

One solution to this problem is to use a guide wire at least double thelength of the delivery catheter. A 320 or 340 centimeter long guide wirecan extend at least about 120 centimeters from the patient's groin,having an accessible region exposed at all phases of delivery catheterplacement. However, the added length makes manipulating and rotating theguide wire very difficult for the treating physician. The extra lengthof the guide wire can be held by additional personnel to prevent theadded wire length from falling to the floor, where it would becomecontaminated. However, not all cardiac catheter laboratories havepersonnel available to maintain control of the long guide wire. In manylabs, the physician is working alone in the sterile field. Advancing adistal embolic protection device delivery catheter over a positioned,favored guide wire would be inherently more efficacious than requiringuse of an unfamiliar, disfavored, or double length guide wire toposition the delivery catheter.

With the distal filter in place, removal of the delivery catheter overthe wire shaft of the distal filter device is ultimately desirable. If asingle length, nominally 140 centimeter long, distal filter device shaftis extending about 20 centimeters proximally from the delivery catheter,a problem is presented. Once the delivery catheter is retracted about 20centimeters, the proximal end of the wire would disappear into theproximal end of the retracting delivery catheter, and control of thedistal filter device wire position lost. If the delivery catheter werefurther retracted, the retraction of the delivery catheter over the wireshaft may pull the distal filter device from its position. Again, adistal protection device having a double length wire shaft can be used.The double length wire shaft allows the delivery catheter to beretracted over the distal filter device shaft while presenting anexposed portion of the wire shaft at all times. As discussed withrespect to the double length guide wire, the added length presentsproblems.

What would be desirable are distal embolic protection device deliverycatheters that can be delivered over the single length guide wirefavored by the treating physician and retracted over single length wireshafts of distal embolic devices.

SUMMARY OF THE INVENTION

The present invention provides improved delivery catheters which can beused to deliver and recover embolic protection devices, including distalembolic filter devices. The catheters are “rapid exchange” or “singleoperator exchange” catheters that can be delivered over a single lengthguide wire. The catheters can also be retracted over a single lengthdistal embolic filter device wire shaft. Catheter assemblies and methodsfor using the assemblies are also provided.

A first catheter according to the invention is a two port catheterhaving two sidewall ports for receiving wires through the ports. One twoport catheter includes a distal region, an intermediate region, and aproximal region for extending out of the patient's body. Some two portcatheters include a tubular body having a tube sidewall and a lumenextending through the tube. The two port catheter can be formed of atube over its entire length or be tubular only in the distal region,being formed of a shaft in the intermediate and proximal regions. Thedistal region can include a distal end port or distal tip port, a distalsidewall port, and a proximal sidewall port. The distal end port and thedistal sidewall port can be dimensioned to allow passage of a guidewire. The proximal sidewall port can be dimensioned to allow passage ofan embolic protection device wire shaft through the port. In a preferredembodiment, the distal end port, the distal sidewall port, and theproximal sidewall port are all dimensioned to allow passage of a 0.014″outside diameter wire through the ports. The catheter inside diametercan be dimensioned to allow passage of an embolic filter in a compressedstate. Some catheters are formed of a tube extending from the distal endto the proximal end, while other catheters are formed of a tube in thedistal region and a shaft or smaller tube in the intermediate andproximal regions. The present invention also includes catheterassemblies which can include a two port catheter, a guide wire, a distalembolic protection device, and a guide catheter adapted to receive thecatheter within.

In use, a guide catheter can be advanced through the vasculature to alocation near the ultimate target site to be filtered. A guide wire canbe advanced through the guide catheter and further to a location nearerthe target site or even distally past the target site.

A distal embolic protection device, for example, a distal embolicprotection filter device having a distal filter element and elongatewire shaft, can be provided. The filter device can be disposed withinthe two port catheter such that the distal filter element lies betweenthe distal sidewall port and the proximal sidewall port, with the wireshaft extending outwardly through the proximal sidewall port to extendproximally along the length of the catheter. In one method, the distalfilter element is radially reduced in shape and advanced distally intothe catheter through the proximal sidewall port. In a preferred method,the distal embolic protection device is back loaded into the catheter bythreading the distal embolic protection device shaft proximal end intothe catheter distal end port and out of the catheter proximal sidewallport. In some embodiments, the distal filter element lies within a bulgebetween the distal sidewall port and the proximal sidewall port.

The guide wire proximal end can be threaded into the catheter distal endport and out of the catheter distal sidewall port to extend proximallyalong the exterior of the catheter. The catheter carrying the distalembolic protection device can then be advanced distally over the guidewire to near the target site. In one method, the catheter is advancedacross the target region while in other methods the catheter is advancedto a position proximal of the target region. The guide wire can then beproximally retracted, and pulled from within the catheter through thedistal sidewall port. The distal filter element is then advanceddistally out of the two port catheter distal end port and allowed toexpand in some methods. In other methods, the distal filter element isheld in a relatively constant position, while the catheter is retractedproximally away from the distal filter element, such that the distalfilter element exits the catheter distal end port and is allowed toradially expand to filter blood in the vicinity of the target site.

When deemed desirable by the treating physician, the catheter can beproximally retracted from the patient by grasping the proximal end ofthe distal embolic protection device shaft while proximally retractingthe catheter. As only a short length of the distal embolic protectiondevice wire shaft extends through the catheter distal region, only ashort added length of wire shaft is required, rather than a doublelength wire shaft as would be required by a conventional catheter. Insome methods, the back loading of the guide wire through the distal endport and out of the distal sidewall port is aided by a collapsible guidewire tube extending from near the distal end port to the distal sidewallport. In other embodiments, the back loading of the guide wire is aidedby a hinged flap or baffle which allows a distally advancing filterelement to move the flap aside but which does not allow a proximallyadvancing guide wire to pass, rather directing the guide wire proximalmovement outward towards the distal sidewall port.

After the therapeutic procedure the catheter may be used to recover theembolic protection device. To do so the proximal end of the embolicprotection device shaft proximal end is threaded into the distal endport and out the proximal sidewall port. The catheter is advanced intothe patient along the device shaft until the catheter tip is immediatelyproximal to the embolic protection device. At this point the embolicprotection device may be partially or totally recovered into the lumenof the catheter by effecting relative motion between the device shaftand the catheter. Subsequently the catheter/embolic protection devicecan be withdrawn as a unit from patient's body.

Another catheter according to the present invention is a three portcatheter, having three sidewall ports. The three port catheter can beformed of a tube over its entire length or be tubular only in the distalregion, being formed of a shaft in the intermediate and proximalregions. The three port catheter can include a distal end portdimensioned to allow passage of a guide wire through the port, but notbeing large enough to allow passage of a filter element. The reducedsize of the distal end port allows for a reduced profile catheter distalend, which can now be narrowly tapered to allow passage through smallerdiameter vessels and past more highly stenosed vessel regions. Thedistal end port can also be tapered to perfectly match the guide wire soas to facilitate smooth passage across vessel irregularities such ascalcium spicules or implanted stents. The three port catheter caninclude a distal sidewall port, an intermediate sidewall port, and aproximal sidewall port. The intermediate sidewall port can bedimensioned to allow passage of a guide wire through the port, and canfunction in a similar manner to the distal sidewall port described withrespect to the two port catheter. In some catheters, the intermediateport is substantially circumferentially aligned with the distal sidewallport.

The proximal sidewall port in the three port catheter can be disposedopposite the distal sidewall port, and can be about 180° opposite thedistal sidewall port. In other respects, the proximal sidewall port canserve the same function as the proximal sidewall port discussed withrespect to the two port catheter. Specifically, the proximal sidewallport can allow passage of the distal embolic protection device wireshaft through the port. The distal sidewall port of the three portcatheter can serve to allow passage of the distal embolic protectiondevice filter through the distal sidewall port. The distal sidewall portcan be a slit in some embodiments, a slot in other embodiments, and around or oval opening in still other embodiments. The three portcatheter is designed such that the distal embolic protection devicefilter element can be carried between the intermediate sidewall port andthe proximal sidewall port, then forced distally through the distalsidewall port rather than through the distal end port as in the two portcatheter. The distal sidewall port can thus be a slit which is forcedopen by the advancement of the filter element. Thus, only the distalsidewall port need be sufficiently large to allow passage of the filter,rather than the distal end port. In some three port catheters, thedistal end port is disposed off center from the central longitudinalaxis of the catheter while the distal sidewall port is substantiallyaligned with the central longitudinal axis of the catheter such thatdistal advancement of the filter element is directed substantiallytoward the distal sidewall port rather than the distal end port.

In use, the guide catheter and guide wire can be advanced to near thetarget site, as with the two port catheter. The distal embolicprotection device can be back loaded through the distal sidewall port,with the wire shaft of the distal embolic protection device exiting theproximal sidewall port, leaving the filter element disposed within thecatheter, preferably between the proximal sidewall port and theintermediate sidewall port. The guide wire proximal end can be threadedthrough the distal end port of the catheter to exit the intermediateport of the catheter. The preloaded catheter can be advanced to near thetarget site. In some methods, the guide wire is left in place aftercatheter placement to preclude the possibility of the filter elementbeing forced into the distal end port. The filter element may also beprovided without a wire tip to address the same problem. In a preferredmethod, the guide wire is retracted and the embolic protection filterbody advanced distally out of the distal sidewall port. With the distalembolic protection device in position, the catheter can be proximallyretracted from the patient. The distal embolic protection device wireshaft need only be slightly longer than the catheter, not twice as long,as only a short length of distal embolic protection device wire shaftlies within the distal region of the catheter.

After the therapeutic procedure the three port catheter can be used torecover the embolic protection device by threading the proximal end ofthe device shaft into the distal sidewall port, out the proximal orintermediate port, and proceeding as described for the two portcatheter.

A third catheter according to the present invention includes a tubehaving a normally open slot extending along most of the tube length. Theslotted catheter preferably has a distal end port dimensioned to allowpassage of a guide wire and a distal embolic protection device filterthrough the port. The catheter preferably has a distal sidewall port toallow passage of a guide wire through the distal sidewall port. Thedistal sidewall port can, but need not, be formed as a widened orenlarged portion of the longitudinal slot extending through thesidewall. The catheter preferably has an unslotted distal most region toprovide column strength for allowing the catheter to be pushed acrossnarrowed, stenosed vessel regions. Some catheters include a funnelportion disposed near the proximal region to aid in introducing thedistal embolic protection device filter into the lumen within thecatheter.

The slot is preferably at least about 0.001″ in width, and can be about0.005″ or even 0.014″ in width. The slot is preferably dimensioned toinhibit the free, transverse movement of a guide wire or distal embolicprotection device wire shaft through the slot. The catheter body ispreferably sufficiently resilient to allow the forced, transversemovement of a wire shaft or guide wire through the slot when suchmovement is desired. The distal-most tip can be located off-center, withthe center of the distal profile being occupied by the slot. Thedistal-most sidewall region can be curved or bent down to form an endwall containing the off-center, distal-most tip.

In use, a guide catheter can be advanced to near the target site,followed by the advancement of a guide wire, as with the two and threeport catheters previously discussed. The guide wire proximal end can bethreaded into the distal end port and out of the distal sidewall port,to extend along the outside of the catheter. The distal embolicprotection device can be preloaded into the distal region of the slottedcatheter. In some embodiments, the distal embolic protection device isfront loaded by distally advancing the device into the proximal end ofthe catheter and further into the catheter distal region. In othermethods, the distal embolic protection device is back loaded byproximally threading the distal embolic protection device wire shaftthrough the catheter distal end port and further proximally through thecatheter until the wire shaft exits the proximal end of the catheter,and the filter element is disposed proximal of the distal sidewall portof the catheter.

The catheter carrying the distal embolic protection device can then beadvanced over the guide wire to near the target site or across thestenosis. The guide wire can be proximally retracted from the catheter,followed by the deployment of the filter element through the catheterdistal end port. When removal of the catheter is desired, the distalembolic protection device wire shaft can be forced transversely throughthe slot in the catheter beginning near the catheter proximal end. Thewire shaft can be held substantially stationary, while the catheter isproximally retracted from the patient. The proximal retraction can becontinued until the wire shaft is disposed within the distal sidewallport of the slot, whereupon the wire shaft can be grasped distal of thecatheter distal end port and the catheter fully removed from thepatient.

In a related method using the slotted catheter, the catheter can beadvanced to across the stenosis or near the target site over the guidewire, with the catheter not yet carrying the distal embolic protectiondevice. The distal embolic protection device can later be advancedthrough the lumen of the slotted catheter to the catheter distal region.The catheter can also be used to recover an embolic protection device asdescribed for the two port catheter.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a highly diagrammatic, cut-away, side view of an assembly fordelivering or recovering a distal embolic protection device, including atwo-port catheter having a distal end port, a distal sidewall port, aproximal sidewall port, and having a guide wire disposed through thedistal sidewall port, and a distal embolic protection device wire shaftextending through the proximal sidewall port, the catheter beingdisposed within a guide catheter;

FIG. 2 is a highly diagrammatic, cutaway side view of the assembly ofFIG. 1, after the catheter has been advanced distally from the guidecatheter, and the guide wire advanced distally from the catheter;

FIG. 3 is a fragmentary, side view of the catheter of FIG. 2, after theguide wire has been proximally retracted from the catheter and thecatheter proximally retracted to expose the distal embolic protectiondevice filter;

FIG. 4 is a fragmentary side view of the distal embolic protectiondevice and catheter of FIG. 3, with the catheter being retracted overthe distal embolic protection device wire shaft;

FIG. 4A is a fragmentary, side view of a catheter having a collapsibleguide wire tube extending between the catheter distal end and the distalsidewall port;

FIG. 4B is an end view of the catheter of FIG. 4A, having a guide wiredisposed within the collapsible guide wire tube;

FIG. 4C is an end view of the catheter of FIG. 4A, having the guide wireremoved and the collapsible guide wire tube collapsed by the advancementof a distal embolic protection device filter;

FIG. 4D is a fragmentary, side view of another catheter having a hingedbaffle for directing a proximally back loading guide wire through thedistal sidewall port while moving aside to allow distal passage of adistal embolic protection device filter;

FIG. 5A is a fragmentary, cut-away, side view of a guide catheter, guidewire, and distal embolic protection device as in FIG. 1, including athree-port catheter having a distal sidewall port for admitting a distalembolic protection device filter, a intermediate sidewall port foradmitting a guide wire, and a proximal sidewall port for admitting adistal embolic protection device shaft or wire;

FIG. 5B is a detailed view from FIG. 5, having a collapsed tubular wallor ramp portion to direct a back loaded distal embolic protection devicewire shaft through the proximal sidewall port;

FIG. 6 is a fragmentary side view of the catheter of FIG. 5, beingadvanced distally from the guide catheter, having the guide wireproximally retracted, and having the distal embolic protection devicefilter advanced distally through the distal sidewall port;

FIG. 7A is a fragmentary, longitudinal, wafer view of one embodiment ofthree port catheter, similar in some respects to the catheter of FIG. 5,having an off-center distal end guide wire port and an axiallyaccessible distal end sidewall port for allowing passage of a distalembolic protection device filter;

FIG. 7B is an end view of the catheter of FIG. 7A;

FIG. 7C is an end view of a catheter having regions of preferentialtearing forming a distal sidewall port;

FIG. 8 is a fragmentary, highly diagrammatic, perspective view of aslotted catheter having a slot extending along substantially most of thecatheter length, the slot being sufficiently narrow to inhibit unwantedtransverse movement of a wire through the slot while being sufficientlyresilient to allow forced transverse movement of a wire through the nowexpanded slot;

FIG. 9 is a side view of the catheter of FIG. 8, carrying a distalembolic protection device, and being advanced within a guide catheterand over a guide wire; and

FIG. 10 is a fragmentary, side view of the catheter of FIG. 9, beingadvanced distally from the guide catheter, having the guide wireproximally withdrawn, and the catheter proximally withdrawn from thedeployed distal embolic protection device filter by forcing the distalembolic protection device wire or shaft through the slot.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a distal embolic protection device assembly 20 whichcan be used to deliver a distal embolic protection device to a targetsite within the vasculature. Assembly 20 includes a delivery/recoverycatheter 24 disposed within a guide catheter 22. The delivery/recoverycatheter can be used to both deliver and recover a distal embolicprotection filter. The term “delivery catheter”, as used herein, shouldbe understood as including a delivery catheter that can also be used torecover a particulate containing filter. Delivery catheter 24 includes aguide wire 19 and a distal embolic protection device 26 disposed within.The proximal end of assembly 20 is illustrated without any hub or Luerfitting to more clearly illustrate the invention. In a preferredembodiment, a hub, well known to those skilled in the art, can beaffixed to the assembly proximal end to form a fluid-tight seal aboutthe protruding members. Delivery catheters referred to in the presentapplication preferably have no added therapeutic distal devices.Specifically, delivery catheters preferably are single lumen cathetersand have no inflatable or expandable balloons, distal atherectomy burrs,water jet devices, or the like. Some delivery catheters can be coatedwith therapeutic coatings however, including anti-thrombogenic coatings,for example heparin, or with lubricious coatings, for example, hydrogelsor silicone.

Guide catheter 22 includes a distal end 28, a distal region 32, aproximal region 34, a proximal end 36, and a lumen 30 extendingtherethrough. Guide catheters are well known to those skilled in the artand will not be further explained. Delivery catheter 24 can be referredto as a “two-port” catheter, as it has two sidewall ports. Deliverycatheter 24 includes a distal end 40, a distal region 42, a distal portor distal sidewall port 48, a proximal port or proximal sidewall port50, a proximal region 44, a proximal end 46, and a lumen 38 extendingtherethrough. In some embodiments, proximal region 44 of deliverycatheter 24 is formed by a shaft rather than a tube, with catheter lumen38 extending through only a distal region of the delivery device.Delivery catheter 24 also includes a distal end port or distal tip port41, formed at the distal end of the catheter. In one embodiment,proximal region 44, which is proximal of proximal port 50, can be formedby a tube which has been transversely slit and pressed downward proximalof proximal port 50. Guide wire 19 may be seen to include a distal tip60, a distal region 62, a wire or shaft 64, a proximal region 65, and aproximal end 66. Guide wire 19 may be seen to extend proximally fromdistal tip 60, within catheter lumen 38, then extending outwardlythrough distal sidewall port 48 to extend proximally along the outsideof delivery catheter 24.

Referring again to FIG. 1, it may be seen that guide wire 19 has beenthreaded through delivery catheter distal sidewall port 48. In somemethods, guide wire 19 is advanced through guide catheter 22, with guidewire proximal end 66 yet to be threaded into delivery catheter distalend port 41 and out delivery catheter distal sidewall port 48. In thismethod proximal end 66 of the guide wire is threaded into distal end 41of the catheter and out through distal sidewall port 48. This isreferred to as “back loading”. The wire back loading can be aided byarcing the distal region of delivery catheter 24, such that the guidewire proximal end 66 is pressed against the inner wall of the catheternear distal sidewall port 48. In some embodiments, other assistance isgiven to back loading the guide wire into the delivery catheter andthrough the delivery catheter distal sidewall port. Distal embolicprotection device 26 may be seen to include a shaft or wire 74 includinga distal region 72 coupled to a distal filter 70.

Distal filter 70 can be viewed as one type of distal emboli protectionelement. Other distal protection elements which can be included as partof the present invention are occlusive emboli protection elements,including expandable or inflatable elements for blocking fluid flowthrough a vessel. Unless otherwise indicated, occlusive elements shouldbe considered as interchangeable with filter elements in the presentinvention.

Distal embolic protection device shaft 74 may be seen to have a proximalregion 76 and a proximal end 78 extending proximally from guide catheter22. Filter 70 is shown in a compressed, radially reduced profileconfiguration as a result of disposition within delivery catheter 24. Ina preferred embodiment, filter 70 is biased to expand radially outwardwhen not constrained by delivery catheter 24. Distal embolic protectiondevice filter 70 may be seen disposed between proximal sidewall port 50and distal sidewall port 48 in intermediate region 45. Distal embolicprotection device shaft 74 may be seen to lie within catheter lumen 38distal of proximal port 50, then extend through proximal port 50 to theexterior of delivery catheter 24, then extend along the outside ofdelivery catheter 24 over its length.

In one assembly, guide wire 19 is formed of stainless steel or Nitinoland has a safety, spring tip. Guide wire 19 can have a length of betweenabout 130 and 180 cm. in some embodiments. Guide wire 19 can haveradiopaque marker bands along its length. Guide wire 19 may also have anoutside diameter of between about 0.009 and 0.035 inches in someembodiments, and about 0.014 inches in a commonly used embodiment.Delivery catheter 24 can be formed of materials well known to thoseskilled in the art. In one embodiment, the distal region of catheter 24is formed of a softer, more pliable material than the more proximalregions of the catheter. In one embodiment, catheter distal region 42 isformed of a rather floppy, soft material. In one catheter, the distalregion is formed of a polymer such as LDPE, MDPE, or PEBAX. This floppydistal region can be coupled to stiffer intermediate and proximalregions formed of polymers such as HDPE, VESTAMID, or Polyimide. Thefloppy distal region can provide a distal region better adapted toadvance through tortuous vessels while the more rigid intermediate andproximal regions can provide pushability.

Distal embolic protection device 26 is preferably an expandable filterdevice. Filter 70 is well known to those skilled in the art and can be afilter as disclosed in U.S. Pat. No. 6,325,815, European PatentApplication No. 1181900 A2, and PCT Pub. No. WO 96/01951, all hereinincorporated by reference. In one example of the invention, distalembolic protection device shaft 74 is formed of stainless steel and hasan outside diameter of about 0.014 inches.

In one embodiment, the distance between delivery catheter distalsidewall port 48 and distal end 40 is between about 5 and 30 cm. Inanother embodiment, proximal sidewall port 50 is located at a distanceof between about 15 and 50 cm. from distal end 40. In some cathetersaccording to the present convention, distal sidewall port 48 is locatedbetween about 5 and 20 cm. distal of proximal sidewall port 50, and thedelivery catheter can be about 3 Fr. in diameter and about 135 cm long.From inspection of FIG. 1, it may be seen that guide wire 19 is withinlumen 38 only over its length between catheter distal end 40 andcatheter distal sidewall port 48. When advancing delivery catheter 24over guide wire 19, only the added length between catheter distal end 40and distal sidewall port 48 need be added to guide wire 19, rather thandoubling its length. Inspection of FIG. 1 also illustrates that distalembolic protection device shaft 74 is only within lumen 38 of catheter24 over the length between catheter distal end 40 and proximal sidewallport 50. When delivery catheter 24 is retracted over distal embolicprotection device shaft 74, only the wire length between catheter distalend 40 and proximal sidewall port 50 need be added to the shaft 74length, rather than doubling its length. Both distal port 48 andproximal port 50 may be formed as “skives” to aid in threading the guidewire and distal embolic protection device wire shafts through therespective ports and to allow a low entry angle (less than about 5 or 10degrees) between the guide wire or shaft axis and the catheter axis soas to minimize sliding friction between the two.

Ports 48 and 50 can both be skived and dimensioned to allow a distallyand inwardly extending wire to penetrate into the tube lumen at an angleof less than about 10 degrees in some embodiments and less than about 5degrees in other embodiments. Some skived ports have a proximal portsidewall region than is cut at an angle of less than about 10 degrees oreven 5 degrees to support the shallow entry angle. In some embodiments,both the port proximal and distal sidewall portions are cut at an angleof less than about 10 or 5 degrees. The port longitudinal dimension ispreferably the largest dimension of the skived ports, which can be ovalor elongate in shape, to provide for a shallow entry angle. The portalso has a transverse dimension orthogonal to the catheter longitudinalaxis. The port transverse dimension is preferably sized to allow lowfriction guide wire passage. Unless otherwise stated, all sidewall portsin the present application used to receive guide wires or shafts ofembolic protection devices can be skived and have a shallow entry angleof less than about 10 or 5 degrees.

FIG. 2 illustrates delivery catheter 24 after the catheter has beenadvanced distally from guide catheter 22. Guide wire distal tip 60 hasbeen advanced further distally from delivery catheter 24. In somemethods, guide wire 19 is advanced distally through guide catheter 22,followed by the advancement of delivery catheter 24 over guide wire 19.Guide wire 19 can be advanced ahead of delivery catheter 24, anddelivery catheter 24 advanced over guide wire 19. This process can berepeated until the guide wire and the delivery catheter have beenadvanced to the target site. In other methods, guide wire 19 anddelivery catheter 24 can be advanced together across the target site.Guide wire 19 can provide stiffening for delivery catheter 24. In somemethods guide wire 19 is retracted, and distal embolic protection device26 is then advanced through delivery catheter 24. In some methods, theguide wire crosses a lesion, followed by the delivery catheter. In othermethods, the delivery catheter and guide wire together are advancedacross a lesion. As indicated in FIG. 2 filter 70 has been positioned atthe target site, indicated at 80. With distal embolic protection devicefilter 70 in the desired position, guide wire 19 can be retracted.

FIG. 3 illustrates delivery catheter 24, after guide wire 19 has beenretracted proximally through distal sidewall port 48. With guide wire 19no longer present within catheter lumen 38, distal embolic protectionfilter 70 can be distally advanced from delivery catheter 24. In apreferred embodiment, as indicated at 80 and by arrows 82, deliverycatheter 24 is proximally retracted, while distal embolic protectionfilter 70 is held in place by the treating physician grasping andholding the distal embolic protection device shaft proximal region. Byretracting delivery catheter 24, distal embolic protection filter 70 isallowed to expand radially, and preferably expands to provide filtrationacross the entire cross sectional area of the vessel. With distalembolic protection filter 70 in place, in some methods, deliverycatheter 24 can be retracted from the patient. In other methods,delivery catheter 24 can remain in place, and a partially filled filter70 later retracted partially into the catheter to close the filtermouth, and both filter and delivery catheter retracted from the patient.In still other methods, delivery catheter 24 can be retracted from thepatient, an interventional procedure performed over device shaft 74, anddelivery catheter 24 re-introduced over the shaft to recover the filterby closing the filter mouth.

FIG. 4 illustrates distal embolic protection device filter 70, withdelivery catheter 24 being proximally retracted as indicated bydirectional arrows 84. When catheter distal end 40 has been fullyretracted from the patient, distal embolic protection device shaft 74 isexposed, as indicated at 86, and can be grasped by the treatingphysician, leaving only a length between catheter distal end 40 andcatheter proximal sidewall port 50 unavailable for grasping. With distalembolic protection device shaft 74 grasped at 86, delivery catheter 24can be fully retracted from device shaft 74. As can be seen frominspection of FIG. 4, only the added length between catheter distal end40 and catheter proximal sidewall port 50 need be added to distalembolic protection device shaft 74, rather than doubling its length.

FIG. 4A illustrates one delivery catheter 100 having a distal end or tip102, a distal region 104 and a lumen 106 extending therethrough.Delivery catheter 100 further has a collapsible tube 108 disposed withincatheter lumen 106. Collapsible tube 108 can serve as collapsible guidewire tube extending between catheter distal end 102 and distal sidewallport 48. Collapsible tube 108 includes a distal end 112 and a lumen 114extending therethrough. Collapsible tube 108 preferably extends distallyof the delivery catheter distal end and may be of a contrasting color tofacilitate identification of the collapsible tube distinct from thedelivery catheter. Tube 108 further includes a proximal region 116 whichcan be bonded to the catheter sidewall near distal sidewall port 48 toprovide an exit for the guide wire. Distal sidewall port 48 preferablyhas a skived configuration.

FIG. 4B illustrates delivery catheter 100 in an end view. Deliverycatheter 100 has collapsible tube 108 within. Collapsible tube 108 isshown in the open position, having guide wire 19 extending therethrough.Collapsible tube at 108 has a tube wall outer surface 118 facing acatheter tubular wall inner surface 120. Collapsible tube outer surface118 can be bonded to catheter wall inner surface 120. Suitable bondingmethods including adhesives, and heat and solvent welding may also beused to attach collapsible tube 108 to catheter 120. Longitudinalstiffening members 115 may be included in the collapsible wall. Guidewire 19 may be seen extending through collapsible tube lumen 114. Guidewire 19 may extend proximally through the tube and out distal sidewallport 48. Collapsible tube 108 preferably has sufficient column strengthto guide a back loaded guide wire, while being radially weak to collapseand allow passage of a filter. In use, the proximal end of guide wire 19can be inserted into collapsible tube distal end 112, and pushedproximally until the guide wire proximal end extends through distalsidewall port 48. Collapsible tube 108 thus aids in back loading guidewire 19 through delivery catheter 100.

FIG. 4C illustrates delivery catheter 100 having guide wire 19 retractedfrom collapsible tube 108. Collapsible tube 108 is shown in itscollapsed position. Distal embolic protection device filter 70 has beenforced distally forward from its parked position proximal of distalsidewall port 48. Distal embolic protection device filter 70 has thusforced part of collapsible tube 108 aside, collapsing the collapsibletube. Distal embolic protection device filter 70 may then be distallyadvanced from the delivery catheter. Collapsible tube 108 may be made ofany suitable, collapsible polymer, well known to those skilled in theart. Some collapsible tubes are formed of LDPE, while other collapsibletubes are formed of PEBAX, nylon, or polyurethane. Preferably, thecollapsible tube is formed of elastomeric polymer such as polyurethane,silicone, latex, and the like.

FIG. 4D illustrates another delivery catheter, catheter 130. Deliverycatheter 130 includes a distal end port 131, a sidewall 134, and adistal sidewall port 148. Delivery catheter 130 has a hinged flap 132.Hinged flap 132 can be fixedly secured to catheter sidewall 134 justproximal of distal sidewall port 148, as indicated at 136. The hingedflap can be a round flap having a tab for bonding to the sidewall, andany suitable bonding method, for example, solvent welding, adhesive, orheat bonding can be used to affix flap 132 to sidewall 134. Sidewallport 148 can also be skived to ease in threading a guide wire throughthe port. Flap 132 includes a central portion 138 and an extreme endportion 140 which is opposite of bonded portion 136. As indicated byarrow 135, hinged baffle or flap 132 can be forced aside by an advancingdistal embolic protection device filter. In the position shown in FIG.4D, a guide wire can be inserted through catheter distal end port 131until encountering flap 132. The guide wire proximal end will then beforced along flap 132 and guided to sidewall port 148. Hinged baffle orflap 132 thus aids in back loading a guide wire through a catheterdistal end port and out through the distal sidewall port. The hingedbaffle or flap 132 can be formed of any suitable material. Exemplarymaterials include HDPE, PEBAX, nylon, polyimide, PEEK, or liquid crystalpolymer.

FIG. 5A illustrates another distal embolic protection device deliveryassembly 180 including another embodiment of delivery catheter in athree-port delivery catheter 182, having guide wire 19 disposedpartially within, having distal embolic protection device 26 alsodisposed partially within, and being disposed within guide catheter 22.Guide wire 19, distal embolic protection device 26, and guide catheter22 are as previously described with respect to FIG. 1. Delivery catheter182 may be seen to have a distal end 184 having a distal end port 186disposed therein. Delivery catheter 182 further has a distal region 188,a proximal region 190, a proximal end 192, and a lumen 194 extendingtherethrough. As previously discussed, in some embodiments, catheter 182may be formed of a shaft in the proximal region 190.

Delivery catheter 182 may be seen to include a distally tapering outerdiameter over distal region 188. The distally tapering region can act tomore closely approach guide wire 19, and provide support for the guidewire. The distal taper can also act to decrease any gap between guidewire 19 and the inner wall of catheter distal end 184. In the two-portdelivery catheter 24 of FIG. 1, distal end port 41, is large enough topass the filter. In contrast, distal end port 186 need only be largeenough to pass a guide wire, for example a 0.014 inch O.D. guide wire.The smaller profile of delivery catheter distal end 184 cansignificantly reduce the likelihood of catheter 182 snagging or hangingup on a stent or on a stenosed vessel region to be crossed.

Delivery catheter distal region 188 also includes a distal sidewall port189 for admitting a distal embolic protection device filtertherethrough. In some embodiments, distal sidewall port 189 has a roundor oblong or oval shape. In other embodiments, distal sidewall port 189is formed as a slit or slot which can expand to allow passage of anadvancing distal embolic protection device filter therethrough. In someembodiments, distal sidewall port 189 is formed as a slit having astrain relief hole at either end.

Delivery catheter 182 also includes a proximal sidewall port 200.Proximal sidewall port 200 can be dimensioned to allow passage of distalembolic protection device shaft 74. In some embodiments, proximalsidewall port 200 is also large enough to admit passage of filter 70.Port 200 can be skived and dimensioned to receive a guide wire at ashallow entry angle, as previously discussed with respect to othersidewall ports.

In the embodiment illustrated, a flap or ramp region 202 is disposedjust proximal of proximal sidewall port 200. Ramp or flap 202 can act toguide a back loaded distal embolic protection device shaft proximal endthrough proximal sidewall port 200 as the shaft is advanced proximallythrough delivery catheter 182, being forced or guided to exit thecatheter lumen 194 through proximal sidewall port 200. Ramp or flap 202need not be hinged, and can be fixed, in embodiments where a continuouslumen through the delivery catheter is not required. As previouslydescribed, catheter 182 can be formed as a shaft proximal of proximalsidewall port 200.

FIGS. 5A and 5B illustrate one embodiment of delivery catheter sidewallport 200 having ramp 202 formed by making a slit 205 through the tubewall of the catheter, then collapsing the tube wall to form ramp 202,just proximal of proximal sidewall port 200. The collapsed tubular wallcan be held in place through any suitable adhesive or bonding method.The collapsed tube wall thus forms a ramp, which can be used to guide aback loaded distal embolic protection device shaft through proximalsidewall port 200. Alternatively, the lumen can be filled by a solidcylinder with a bias cut end and the cylinder bonded in place.

Referring again to FIG. 5A, delivery catheter 182 also includes anintermediate sidewall port 206, disposed between distal sidewall port189 and proximal sidewall port 200. As may be seen from inspection ofFIG. 5A, distal sidewall port 189 can be disposed on the opposite sideof delivery catheter 182 from proximal sidewall port 200. Proximalsidewall port 200 can thus be located 180° away from distal sidewallport 189. In some embodiments, intermediate sidewall port 206 issubstantially aligned with distal sidewall port 189. Intermediatesidewall port 206 can be dimensioned to receive guide wire 19therethrough. In some embodiments, intermediate sidewall port 206 isskived, as previously discussed with respect to other wire admittingsidewall ports In one embodiment, distal sidewall port 189 is locatedbetween about 0.2 and 5.0 centimeters from catheter distal end 184.Intermediate sidewall port 206 can be located between about 5 and 30centimeters from distal end 184. Proximal sidewall port 200 can belocated between about 15 and 50 centimeters from catheter distal end184. In some embodiments, distal sidewall port 189 and proximal sidewallport 200 are disposed between about 5 and 20 centimeters apart.

In use, assembly 180 can be similar in many respects to assembly 20,discussed with respect to FIG. 1. Guide wire 19 can be advanced throughguide catheter 22 to the target site, as previously discussed. Guidewire 19 can be threaded through catheter distal end port 186, exitingthe delivery catheter through intermediate sidewall port 206, thenrunning along the exterior of the delivery catheter to beyond thecatheter proximal end. In some methods, guide wire 19 is front loadedthrough delivery catheter 182 by forcing guide wire distal tip 60distally through intermediate sidewall port 206 then out deliverycatheter distal end port 186. The catheter can thus be threaded over theguide wire but remain outside of the patient until the combination isjointly advanced to a region of interest.

Distal embolic protection device 26 can have the proximal end of distalembolic protection device shaft or wire 74 proximally back loadedthrough distal sidewall port 189, with distal embolic protection devicefilter 70 in a compact configuration and pulled proximally towardproximal sidewall port 200. In other embodiments, distal embolicprotection device filter 70 is advanced or front loaded through proximalsidewall port 200 to the “parked” position between proximal sidewallport 200 and intermediate sidewall port 206.

Guide catheter 22 can be advanced to a coronary ostium, or otherlocation. Guide wire 19 can then be advanced through the guide catheterand further to a target site to be protected. In some methods, the guidewire proximal end can be threaded through catheter distal end port 186and out intermediate sidewall port 206. Delivery catheter 182, carryingdistal embolic protection device 26, can be advanced over guide wire 19distally from guide catheter 22 and beyond the site to be protected.With delivery catheter 182 and carried distal embolic protection device26 in position, guide wire 19 can be proximally retracted, as previouslydiscussed.

FIG. 6 illustrates delivery catheter 182, after guide wire 19 has beenproximally retracted through intermediate port 206. Distal embolicprotection device 26 can be distally advanced through distal sidewallport 189, thus exiting delivery catheter 182. In some methods, deliverycatheter 182 is proximally retracted, while maintaining the position ofdistal embolic protection device filter 70. With distal embolicprotection device filter 70 in position, and suitably expanded to filterparticulates, delivery catheter 182 can be proximally retracted overdistal embolic protection device shaft or wire 76. As may be seen frominspection of FIG. 6, only the length of distal embolic protectiondevice shaft 76 between proximal sidewall port 200 and distal sidewallport 189 is disposed within delivery catheter 182. This requires only asmall added length to distal embolic protection device shaft 76 toeffect catheter removal from shaft 76, rather than doubling the shaftlength. In some embodiments, a suitable ramp or bump within deliverycatheter 182 can further guide distal embolic protection device filter70 through distal sidewall port 189. In some embodiments, a hinged flapor baffle, similar in some respects, but not others, to the hingedbaffle described with respect to FIG. 4 can be used. In this embodiment,the hinged baffle can allow proximal movement of a back loaded guidewire through distal end port 186 while resisting distal movement ofdistal embolic protection device 70 against the flap. In some methods,the distal embolic protection device has no long distal tip, forexample, no 0.014 inch O.D. wire tip, as the tip may try to exit distalend port 186. In other methods, the guide wire is left within distal endport 186, in order to prevent the filter body from attempting to exitthe distal end port.

FIG. 7A illustrates one embodiment of delivery catheter 220 having adistal region 226 which is asymmetric, having a substantially straightportion 228 and a tapering portion 230. Tapering portion 230 has adistal sidewall port, slit or slot 232 therethrough. A distal end port222 is disposed within distal end 224 of delivery catheter 220. In someembodiments, distal end port 222 is dimensioned to accept a guide wiretherethrough, but not a distal embolic protection device filter. Thiscan act to prevent unwanted attempted or partial distal passage of adistal embolic protection device filter through distal end port 222.Distal end port 222 is preferably located off-center from the centrallongitudinal axis of the delivery catheter 220. In some embodiments,slit 232 is located to be axially aligned with the longitudinal centralaxis of the delivery catheter 220.

FIG. 7B illustrates delivery catheter 220, viewed from the distal end.The off-center location of distal end port 222 and the downwardlyslanting orientation of distal sidewall port 232 toward distal end port222 may also be seen. Distal sidewall port 232 may also be described asbeing accessible from the delivery catheter distal end when approachedalong the central longitudinal axis through the catheter, either fromwithin the catheter or from the distal end of the catheter. Theorientation of distal sidewall port 232 can allow a distal embolicprotection device filter to be more easily distally forced from catheter222 and out distal sidewall port 232.

FIG. 7C illustrates another embodiment of delivery catheter in catheter240. Delivery catheter 240 is similar in some respects to deliverycatheter 220, discussed with respect to FIGS. 7A and 7B. Deliverycatheter 240 includes a “tearable” distal sidewall port 242 and a distalend port 244. Distal sidewall port 242 can be formed as a region ofpreferential tearing or weakness. The preferential tearing can be formedby perforating the sidewall of the catheter or cutting partially throughthe sidewall of the catheter, such that a distal embolic protectiondevice being advanced distally against the region of preferentialtearing can be forced through the preferential tearing region and out ofthe delivery catheter. In some embodiments, the preferential weakness ofthe distal sidewall port and/or the distal end port can be formed bymaking the catheter with an extremely thin wall in the regions to betorn.

FIG. 8 illustrates another embodiment of the present invention, in a“slotted” delivery catheter. Slotted delivery catheter 300 may be seento include a distal end 302, a distal end port 304, a distal region 306,a proximal region 308, and a lumen 303. Slotted delivery catheter 300can include a slot 310 extending over a substantial portion of thelength of the catheter, and can have a distal unslotted region 311 whichcan provide column strength. Slot 310 preferably has a width of at leastabout 0.001 inch. Slot 310 is preferably dimensioned to significantlyinhibit the passage of a guide wire, for example a 0.014 inch outsidediameter guide wire, through the slot. Slot 310 preferably has a wideneddistal region or sidewall port 312 dimensioned to freely admit passageof a guide wire therethrough. In some embodiments, distal sidewall port312 is dimensioned to be about two thousandths of an inch larger thanthe outside diameter of the guide wire to be used in conjunction withthe delivery catheter, or, in the example given, 0.016 inches in width.Port 312 can be skived to provide a shallow entry angle, as previouslydiscussed with respect to other ports. Slot 310 continues to a slotproximal end 316. In a preferred embodiment, slot 310 extends to aproximal end port 318 which is longitudinally accessible from theproximal end of the catheter. Proximal region 308 can include an offsethandle 312, shown schematically in FIG. 8. Proximal end port 318 islarge enough to admit the wire or shaft of a distal embolic protectiondevice therethrough.

Delivery catheter 300 preferably has a tube wall 322 sufficiently stiffto inhibit the unwanted transverse or radial movement of a wire or shaftthrough the slot, yet sufficiently resilient to allow a wire or shaft tobe forced through the slot, upon the application of sufficient force orpressure, as would not be encountered in use within the human body.Delivery catheter 300 can be formed of polymers well known to thoseskilled in the art, for example, PEBAX, nylon, PET, Polyimide or HDPE.Slot 310 is preferably between about 0.001 and 0.032 inches in width,more preferably between about 0.001 and 0.010 inches in width. Invarious embodiments, slot 310 is about 0.001, 0.005, 0.007, 0.009 and0.010 inches in width and distal sidewall port 312 is at least about0.016 inches in width. For peripheral applications where 0.035 inchguide wires are commonly used, slot dimensions can be adjustedaccordingly. Slot 310 may be seen to terminate distally at distalsidewall port 312. In one embodiment, unslotted portion 311 between slotsidewall port 312 and catheter distal end 302 is between about 5 and 30centimeters, preferably being at least about 5 centimeters, morepreferably being at least about 2 centimeters in length.

FIG. 9 illustrates delivery catheter 300, in use within guide catheter22, disposed over guide wire 19, and carrying distal embolic protectiondevice 26 within. As can be seen from inspection of FIG. 9, guide wire19 lies within lumen 303 of delivery catheter 300 and extends proximallythrough lumen 303, exiting delivery catheter 300 through distal sidewallport 312. Distal embolic protection device shaft or wire 76 may be seento lie within lumen 303. Guide wire 19, delivery catheter 300, anddistal embolic protection device 26 can be advanced to a target site,substantially as previously described with respect to other embodiments.Guide wire 19 can extend proximally outside of delivery catheter 300,exiting proximally near the point of entry into the patient.

FIG. 10 illustrates distal embolic protection device 26, having distalembolic protection device distal filter 70 being held in position whiledelivery catheter 300 is proximally retracted, thereby forcing filter 70from catheter distal end port 304. Guide wire 19 had previously beenproximally withdrawn through distal sidewall port 312, as previouslydescribed with respect to other embodiments. FIG. 10 further illustratesslot 310 in proximal region 308, having guide wire 19 being forcedtransversely through slot 310, thereby forcibly widening the slot widthto allow exit of wire 76 through slot 310. The proximal end of distalembolic protection device shaft or wire 76 can be held as indicated at330 by the treating physician while proximally retracting the deliverycatheter as indicated at 332. This can continue as the distal embolicprotection device shaft or wire is maintained in a substantiallyconstant position while removing the slotted delivery catheter over theconstant position distal embolic protection device shaft or wire 76. Inone method, delivery catheter 300 is proximally retracted until theshaft or wire 76 reaches distal sidewall port 312. At this point, thedelivery catheter can be further proximally retracted to expose thedistal embolic protection device shaft distally extending from distalend port 304 of catheter 300. The exposed shaft 76 can be grasped, andthe delivery catheter fully retracted from over the end of the distalembolic protection device shaft or wire 76. The added length to thedistal embolic protection device shaft or wire required to allow removalof the delivery catheter over the shaft may be seen to be only thedistance between the distal end port 304 and distal sidewall port 312,rather than double the length of the shaft.

The foregoing detailed description should be read with reference to thedrawings, in which like elements in different drawings are numberedidentically. The drawings, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope of theinvention. Several forms of invention have been shown and described, andother forms will now be apparent to those skilled in art. It will beunderstood that embodiments shown in drawings and described above aremerely for illustrative purposes, and are not intended to limit scope ofthe invention as defined in the claims which follow.

1. A sheath for deployment of a medical device comprising: an elongatetubular member having a proximal end, a distal end, and a lumentherebetween; a first opening in the lumen at the distal end of thetubular member; a second opening in the lumen proximal the distal end ofthe tubular member; wherein the first opening and the second opening areadapted to pass an elongate member therethrough; and a third opening inthe lumen proximal the second opening in the lumen.
 2. The sheath ofclaim 1, wherein the second opening is a short distance proximal to thedistal end and the third opening is a short distance proximal to thesecond opening.
 3. The sheath of claim 1, wherein the first opening andthe third opening is adapted to pass a support wire therethrough.
 4. Thesheath of claim 3, wherein the support wire further comprises anexpandable filter mounted on a distal end of the support wire.
 5. Thesheath of claim 4, wherein the support wire and filter are positionedwithin the lumen of the elongate tubular member.
 6. The sheath of claim1, further comprising an endoluminal medical device.
 7. The sheath ofclaim 6, wherein the endoluminal medical device is selected from thegroup consisting of an angioplasty catheter, a stent-deploymentcatheter, an atherectomy catheter, an intravascular ultrasound catheter,a filter catheter, a guidewire, and an aspiration catheter.
 8. Thesheath of claim 1, wherein the proximal end of the elongate tubularmember includes a hemostatic valve.
 9. The sheath of claim 1, whereinthe second opening is located 50 centimeters or less from the distalend.
 10. The sheath of claim 1, wherein the elongate member passedthrough the first opening and the second opening is a guidewire.
 11. Asheath for deployment of a medical device comprising: an elongatetubular member having a proximal end, a distal end, and a lumentherebetween; a first opening in the lumen at the distal end of thetubular member; a second opening in the lumen proximal the distal end ofthe tubular member; and a guidewire that passes through the secondopening, through the lumen of the elongate tubular member, and throughthe first opening; and a support wire having a proximal end and a distalend, the support wire being positioned within at least a portion of thelumen of the elongate tubular member.
 12. The sheath of claim 11,wherein the support wire is adapted to receive an endoluminal medicaldevice.
 13. The sheath of claim 11, further comprising a third openingin the lumen proximal the second opening in the lumen.
 14. The sheath ofclaim 13, wherein the second opening is a short distance proximal to thedistal end and the third opening is a short distance proximal to thesecond opening.
 15. The sheath of claim 11, wherein the second openingis located 50 centimeters or less from the distal end.
 16. The sheath ofclaim 11, wherein the second opening is located 10 centimeters or lessfrom the distal end.
 17. A sheath for deployment of a medical devicecomprising: an elongate tubular member having a proximal end, a distalend, and a lumen therebetween; a first opening in the lumen at thedistal end of the tubular member; a second opening in the lumen proximalthe distal end of the tubular member; wherein the second opening isproximal the distal end of the tubular member by a distance of 50centimeters or less; and wherein the first opening and the secondopening are adapted to pass an elongate member therethrough.
 18. Thesheath of claim 17, further comprising a third opening in the lumenproximal the second opening in the lumen, wherein the third opening is ashort distance proximal to the second opening.